New Technologies to Help Manage ADHD

Developing New Technologies to Improve ADHD Medication Continuity

Cluster randomized controlled trial to evaluate the general effectiveness of intervention compared to control on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: enhanced myADHDportal.com; Other: treatment as usual standard portal

Detailed Description

This cluster randomized controlled trial will evaluate the general effectiveness of the intervention (e.g. enhanced myADHDportal.com), compared to control (e.g. treatment as usual standard portal), on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45237
      • William B Brinkman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents of children are eligible to participate if

  1. their child receives ADHD care at one of the pediatric primary care practices that is partnering to conduct this trial
  2. child being registered on myADHDportal.com to initiate child assessment of ADHD
  3. child age 6-10 years
  4. child must not have been previously treated with ADHD medication
  5. child prescribed ADHD medication within 12 months of enrolling in the study

Exclusion Criteria:

• Unable to read and speak English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enhanced myADHDportal.com; Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child	Other: enhanced myADHDportal.com; Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child
Active Comparator: treatment as usual standard portal; Standard version of myADHDportal.com web software	Other: treatment as usual standard portal; Standard version of myADHDportal.com web software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Continuity: The Number of Days Covered With Medicine	the number of days covered with medicine will be calculated from audit of prescriptions written	first 6 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale)	Necessity to concerns differential score, range -4 to 4, positive scores mean necessity outweighs concerns, negative scores mean that concerns outweigh beliefs about necessity	6 months after starting treatment
Parent-reported Decisional Conflict (Decisional Conflict Scale)	Total score calculated from parent-report on the Decisional Conflict Scale, range 0 to 100; higher scores are worse	6 months after starting treatment
Parent Trust in Provider (Trust in Provider Scale)	Total score calculated from parent-report on the Trust in Provider Scale, range 10 to 50 with higher scores better (more trust)	6 months after starting treatment
Working Alliance Inventory	range 12-60, higher scores better (more alliance)	6 months after starting treatment
Parent Perceived Social Support (Perceived Social Support Scale)	Total score calculated from parent-report on the Perceived Social Support Scale, range 12-84, higher score better (more social support)	6 months after starting treatment
Parent Distress (Parenting Stress Index - Short Form)	Parental distress subscale score calculated from the Parenting Stress Index - Short Form; range 36-180, higher scores is worse (more stress)	6 months after starting treatment
Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale	Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale	6 months after starting treatment
Total Number of myADHDportal.Com Log-ins by Parent		6 months after starting treatment
Total Number of Measures Completed by Parents to Track Child Response to Treatment		6 months after starting treatment

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: William Brinkman, MD, MEd, MSc, Cincinnati Children's

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: R34MH101155 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No